Clinical Outcomes of Cryobiopsy for Peripheral Pulmonary Lesions - A Prospective Pilot Study

  • STATUS
    Recruiting
  • End date
    Jun 1, 2023
  • participants needed
    50
  • sponsor
    Pusan National University Hospital
Updated on 3 May 2022

Summary

As the former radial endobronchial ultrasound (R-EBUS) guided transbronchial forcep biopsy of peripheral pulmonary nodules has some limitations, the purpose of this study is to investigate a novel biopsy technique, transbronchial cryobiopsy, in patients with peripheral pulmonary nodules.

Description

This is a prospective, single arm, open label trial to assess the diagnostic accuracy and safety of the transbronchial cryobiopsy in patients with peripheral pulmonary nodule using a 1.1mm cryoprobe, combined with bronchoscope (with/without guide sheath), R-EBUS, virtual bronchoscopy navigation, and fluoroscopy.

Details
Condition Lung Nodule
Treatment Transbronchial Cryobiopsy
Clinical Study IdentifierNCT05046093
SponsorPusan National University Hospital
Last Modified on3 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient with peripheral lung nodule less than 30mm on CT scan referred for biopsy
Age ≥ 18
Written informed consent after participant's information

Exclusion Criteria

Central lesion (visible on bronchoscope) or presence of metastatic lymph node (not requiring radial EBUS)
Pure GGO lesion
Patients at increased risk of bleeding
Cannot stop agents such as antiplatelet agent or anticoagulant therapy
Coagulopathy: Thrombocytopenia (< 100,000/mm3) or prolonged PT (INR > 1.5)
Patient with existing or risk of pulmonary and cardiovascular decompensation
Intolerance to sedation
Vulnerable groups such as pregnant woman, breast feeding, etc
Previously diagnosed cancer patient who needs re-biopsy for genetic susceptibility
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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